Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
(Lumbar CvS Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Overseen ByDavid Provenzano
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Avanos Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing two methods of using heat to treat chronic lower back pain. It targets patients whose pain comes from specific joints in the lower back. The treatment works by blocking pain signals from certain nerves. For years, heat has been used for comfort and pain relief and is recommended as a first-line therapy in many clinical guidelines.
Eligibility Criteria
Inclusion Criteria
You are experiencing moderate to severe pain, with a score of 6 or higher on a pain scale from 0 to 10.
You have chronic low back pain for at least 3 months that is caused by a specific condition in your lower back joints. You have tried different non-surgical treatments like exercise, pain relief medication, and activity modification but haven't gotten enough relief.
If you take certain types of pain medication, such as Neurontin or Cymbalta, you must have been taking the same amount for at least 6 weeks before the study. You cannot change your dosage during the study without permission from the study doctor.
+6 more
Exclusion Criteria
Your body has physical differences that would make it difficult to follow the study's procedures.
You have a medical condition that weakens your immune system and it is not under control.
You have severe narrowing in your spine that is causing nerve-related pain or difficulty walking.
+25 more
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Cooled RadiofrequencyExperimental Treatment1 Intervention
Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Group II: Conventional RadiofrequencyActive Control1 Intervention
Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ochsner Baptist Medical CenterNew Orleans, LA
International Spine & Pain Performance CenterWashington, United States
The Center for Clinical ResearchWinston-Salem, NC
Pain Diagnostics and Interventional CareSewickley, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Avanos MedicalLead Sponsor